Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants

Study Identifier
1932-702-008
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
  • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Aged appearance is often caused by an infraorbital hollowing, which is characterized as a sunken appearance of the eye that results in the casting of a dark shadow over the nasal lower eyelid, giving a fatigued appearance. This study will assess how safe and effective JUVEDERM VOLBELLA with Lidocaine is in correcting infraorbital hollowing in adult participants in China.

    VOLBELLA with Lidocaine is an investigational product being developed for the correction of infraorbital hollowing. Participants are randomly assigned to 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 on 4 chance that participants will be assigned to control group. Around 160 adult participants seeking correction of infraorbital hollowing will be enrolled at approximately 8 sites across China.

    Participants in treatment group will receive VOLBELLA with Lidocaine injections on Day 1 and followed for 12 months. Participants in control group are followed for 3 months. Participants in Control group can opt to receive VOLBELLA with Lidocaine injection after completion of 3 months and followed for 9 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Beijing Hospital /ID# 227588
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    Peking Union Medical College Hospital /ID# 227590
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    Peking University First Hospital /ID# 227593
    Xicheng District, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    Nanjing Drum Tower Hospital /ID# 241042
    Nanjing, Jiangsu, China, 210008
    Status
    Not applicable
    Location
    Zhongda Hospital Southeast University /ID# 241040
    Nanjing, Jiangsu, China, 210009
    Status
    Not applicable
    Location
    The Affiliated Hospital of Qingdao University /ID# 227592
    Qingdao, Shandong, China, 266000
    Status
    Not applicable
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